Onsite Tobacco Cessation Treatment for Patients With PAD

NCT05469698 | Active Not Recruiting

• 1 other identifier: 12774
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco cessation treatment is needed for individuals with peripheral artery disease (PAD) to improve symptoms, lower cardiovascular risk, and prevent amputation. While such treatment is effective, many PAD patients do not receive cessation therapy. Participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. We hypothesize that integrating tobacco cessation services into a dedicated PAD clinic (OU CVI Limb Preservation Clinic) can improve tobacco cessation rates and improve PAD-related health outcomes in this at risk population.

Conditions

Tobacco Cessation; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Biochemically confirmed abstinence

  We will measure the biochemically-confirmed self-reported smoking cessation rate at 13 weeks post-enrollment (a cessation rate of ≥ 15-20% will be a sign of feasibility).

  13 weeks post enrollment

Secondary Outcomes (1)

• Rate of enrollment

  Duration of the study (approximately 6 months)

Other Outcomes (1)

• Improvements in PAD

  Baseline to 13 weeks post enrollment

Study Arms (1)

Standard Care

OTHER

All participants will receive standard care by the Tobacco Treatment Research Program. This includes nicotine replacement therapy such as patches, gum, or lozenges, counseling by a Tobacco Treatment Specialist, and complete questionnaires.

Behavioral: Tobacco Treatment Research Program Standard Care

Interventions

Tobacco Treatment Research Program Standard Care BEHAVIORAL

Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.

Standard Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have diagnosed peripheral artery disease
• Tobacco user
• years of age or older
• Willing/able to attend all study visits
• Be able to read, speak, and understand English

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Darla E Kendzor, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 22, 2022
• Study Start: August 16, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be made available to investigators upon request after publication of the primary study findings.
• Access Criteria: Data sharing agreement

Locations

US (1)